Premature BirthNCT00819715
Electrogastrography in Small for Gestational Age Preterm Infants
An observational study of Premature Birth, run by Meir Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether small for gestational preterm infants, have delayed or decrease gastric motility compared to appropriate for gestational age preterm infants. Read more about this study
- Who is it for?
- Ages 1 day to 2 days
- Conditions the study is for
- Premature Birth
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2008to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 2 days
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants >31 weeks, - 37 weeks , healthy, on enteralfeeds
Who may be able to join
- preterm infants 32-37 weeks' gestation
- No sepsis or ventilation
- Feeding orally or with NG tube.
- Age <48 h to be included
Who cannot join
- GE reflux
- Medication that affect gastric motility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrogastrography in Small for Gestational Age Preterm Infants Compared to Appropriate for Gestational Age Infants
The purpose of this study is to determine whether small for gestational preterm infants, have delayed or decrease gastric motility compared to appropriate for gestational age preterm infants.
- Conditions
- Premature Birth
- Keywords
- Preterm infants, small for gestational age, electrogastrography
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Small for gestational age preterm infants | |
| 2 | Appropriate for gestational preterm infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
EGG compatible with age
Measured: day 1 and day 7 after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startJun 2008
- Primary completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Shmuel Arnon, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819715
- Sponsor's protocol ID
- 0244-07-MMC
- Status last verified
- Jun 2009
- First submitted
- 8 Jan 2009
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liang J, Co E, Zhang M, Pineda J, Chen JD. Development of gastric slow waves in preterm infants measured by electrogastrography. Am J Physiol. 1998 Mar;274(3):G503-8. doi: 10.1152/ajpgi.1998.274.3.G503.
PubMed 9530151
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrogastrography in Small for Gestational Age Preterm Infants Compared to Appropriate for Gestational Age Infants
- ClinicalTrials.gov ID
- NCT00819715
- Acronym / sponsor ID
- 0244-07-MMC
- Conditions
- Premature Birth
- Keywords
- Preterm infants, small for gestational age, electrogastrography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jan 2010 (actual)
- First posted
- 9 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether small for gestational preterm infants, have delayed or decrease gastric motility compared to appropriate for gestational age preterm infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Small for gestational age preterm infants |
| 2 | – | –Appropriate for gestational preterm infants |
Who may qualify
- Ages
- 1 day to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants >31 weeks, - 37 weeks , healthy, on enteralfeeds
Key inclusion criteria (4 listed)
- preterm infants 32-37 weeks' gestation
- No sepsis or ventilation
- Feeding orally or with NG tube.
- Age <48 h to be included
Key exclusion criteria (2 listed)
- GE reflux
- Medication that affect gastric motility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EGG compatible with age
Time frame: day 1 and day 7 after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
- Results publication: PubMed 9530151Liang J, Co E, Zhang M, Pineda J, Chen JD. Development of gastric slow waves in preterm infants measured by electrogastrography. Am J Physiol. 1998 Mar;274(3):G503-8. doi: 10.1152/ajpgi.1998.274.3.G503.
Related trials for Premature Birth
Recruiting
Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)
Preterm, Preterm Infant Development
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Active, not recruitingObservational study
Effects of Transitional Circulation in ELBW Infants
Neonatal Prematurity, Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shmuel Arnon, MD principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EGG compatible with age (time frame: day 1 and day 7 after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00819715, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2010.